Who else makes this device?

Name: Carbon Dioxide Standard, Level F
Brand: Carbon Dioxide Standard, Level F

Clinical Chemistry › Test SystemsCalibrator, Multi-Analyte Mixture

Carbon Dioxide Standard, Level F

Catalogue number 9216, listed by Verichem Laboratories, Inc., United States, under Calibrator, Multi-Analyte Mixture. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code JIX
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for Carbon Dioxide Standard, Level F
Listed by	Verichem Laboratories, Inc., United States
FDA product code	JIX
Device type	Calibrator, Multi-Analyte Mixture
Device class	Class 2
Regulation	21 CFR 862.1150
Establishment	Contract manufacturer, Manufacturer
510(k)	K112834
Record published	2018-01-16
Record revised	2018-07-06 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Carbon Dioxide Standard, Level F
Catalogue number	Size	Status
9216		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stat Profile	Nova Biomedical Corporation	54
BioPlex 2200	Bio-Rad Laboratories Inc.	32
Plasma Calibrator Set	Chromsystems Instruments & Chemicals Gmbh	22
Phoenix Diagnostics	Phoenix Diagnostics, Inc.	20
Nova	Nova Biomedical Corporation	15
Plasma Calibration Standard	Chromsystems Instruments & Chemicals Gmbh	15
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	15
Architect	Abbott Laboratories	11
Alinity	Abbott Medical	10
Synchron	Beckman Coulter, Inc.	9
Architect	Abbott Medical	9
Urine Calibration Standard	Chromsystems Instruments & Chemicals Gmbh	8

Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K112834	2012-03-28
K974290	1997-12-19
K973345	1997-10-29
K972333	1997-07-23
K875285	1988-09-02
K882116	1988-06-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.